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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / September 2025 / K251227

510(k) cleared

da Vinci Surgical System (IS5000)

Intuitive Surgical, Inc. · Sep 8, 2025 · K251227

FDA cleared the da Vinci Surgical System (IS5000) from Intuitive Surgical, Inc. on Sep 8, 2025 under K251227, a traditional 510(k). The device falls under product code NAY, System, Surgical, Computer Controlled Instrument, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Apr 21, 2025. The decision came 140 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Intuitive Surgical, Inc. has 8 other decisions in the tracker over the last 12 months: K253702 (Intuitive Endoluminal Gastrointestinal System (IG1000)), K261824 (da Vinci Surgical System, Model IS5000), K261249 (Universal Seal (5-12 mm)), K260695 (da Vinci Firefly Imaging System).

Questions & Answers

What did FDA clear under K251227?

K251227 is the FDA 510(k) for da Vinci Surgical System (IS5000), submitted by Intuitive Surgical, Inc.. FDA's decision date was Sep 8, 2025, under product code NAY (System, Surgical, Computer Controlled Instrument).

Who makes the da Vinci Surgical System (IS5000)?

Intuitive Surgical, Inc., based in Sunnyvale, CA, is the applicant of record for K251227.

How long did the K251227 review take?

FDA received the submission on Apr 21, 2025 and issued its decision on Sep 8, 2025, 140 days later.

← All decisions in September 2025